Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01197612
First received: August 30, 2010
Last updated: September 8, 2010
Last verified: August 2010

August 30, 2010
September 8, 2010
September 2010
Not Provided
olfaction [ Time Frame: 3 weeks post-op ] [ Designated as safety issue: No ]
will be measured with the University of Pennsylvania Smell Identification Test (UPSIT)
Same as current
Complete list of historical versions of study NCT01197612 on ClinicalTrials.gov Archive Site
  • Sinonasal health [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    will be assessed with the Perioperative Sinus Endoscopy score (POSE)
  • Olfaction [ Time Frame: 24 weeks post-op ] [ Designated as safety issue: No ]
    Scored with the University of Pennsylvania Smell Identification Test
  • Sinonasal health [ Time Frame: 24 weeks post-op ] [ Designated as safety issue: No ]
    Assessed with Perioperative Sinus Endoscopy (POSE) score
Same as current
Not Provided
Not Provided
 
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.

Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
  • Chronic
  • Sinusitis
  • Polyposis
Drug: pulmicort
applied to nasal packing after surgery
Other Names:
  • pulmicort
  • budesonide
all subjects
each subject serves as their own control
Intervention: Drug: pulmicort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • hyposmia and nasal obstruction for >12 weeks
  • bilateral nasal polyposis
  • candidate for surgery

Exclusion Criteria:

  • immunocompromised
  • non-English speaking
  • prisoner
  • pregnant/lactating
  • will not attend f/u appt's
Both
18 Years and older
No
Contact: Garrett R Griffin, MD 703-628-6424 gargriff@med.umich.edu
United States
 
NCT01197612
HUM00029273
Yes
Garrett Griffin, University of Michigan Department of Otolaryngology
University of Michigan
American Rhinologic Society
Principal Investigator: Garrett R Griffin, MD University of Michigan
University of Michigan
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP